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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2023

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At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms UNIFI
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 17 Oct 2023 Results of matching-adjusted indirect comparisons (MAIC) of the efficacy and safety of Upadacitinib vs Vedolizumab, Ustekinumab and Tofacitinib in the phase 3 maintenance studies U-ACHIEVE, GEMINI-1, UNIFI & OCTAVE Sustain, presented at the 31st United European Gastroenterology Week.
    • 09 May 2023 Results (placebo (n=145 subjects), UST 130 mg (n=155 subjects)) assessing the underlying molecular mechanism of action of ustekinumab in ulcerative colitis, presented at the Digestive Disease Week 2023.
    • 09 May 2023 Pooled data from U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026) and UNIFI (NCT02407236) studies evaluating the comparison of efficacy and safety of Upadacitinib versus Ustekinumab as induction therapy, presented at the Digestive Disease Week 2023.
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